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Additional Effects of Vagus Nerve Stimulation on Motor Functions of Upper-limb in Stroke

R

Riphah International University

Status

Completed

Conditions

Stroke (CVA) or TIA

Treatments

Other: Vagus nerve stimulation with task oriented training
Other: Task oriented training

Study type

Interventional

Funder types

Other

Identifiers

NCT05771805
Irrij Javed Jadoon

Details and patient eligibility

About

The study aims to determine the additional effects of vagus nerve stimulation with task-oriented training on motor functions of upper-limb in stroke

Full description

Stroke is a clinical syndrome characterized by rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours or leading to death with no apparent cause. Nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after stroke. The study aims to determine the additional effects of vagus nerve stimulation with task-oriented training on motor functions of upper-limb in stroke. The idea of stimulating the vagus nerve to modify central brain activity has been pursued. Vagus nerve stimulation (VNS) paired with rehabilitative training enhances recovery of function in models of stroke and is currently under investigation for use in chronic stroke patients. Compared to traditional stimulation, noninvasive VNS seems to be safer and more tolerable.

Enrollment

50 patients

Sex

All

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Sub-Acute stroke (3 months to 6 months)
  • Between grade 0 and grade 2 on modified Ashworth scale.
  • Patients who will be able to walk without assisted devices and can stand for 2 minutes.
  • Either type Ischemic or Hemorrhagic
  • Age bracket 40-60 Years

Exclusion criteria

  • Previous surgical intervention on vagus nerve
  • Severe pain in upper extremity
  • MoCA score of less than 10

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Vagus nerve stimulation with task oriented training
Experimental group
Description:
Vagus nerve stimulation with task oriented training
Treatment:
Other: Vagus nerve stimulation with task oriented training
Task oriented training
Active Comparator group
Description:
Task oriented training alone
Treatment:
Other: Task oriented training

Trial contacts and locations

1

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Central trial contact

Arshad Malik, PhD

Data sourced from clinicaltrials.gov

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